Data Management Guidance from MHRA, WHO, PIC/S and China

December 31, 2016

Major regulatory authorities published guidance addressing data management and data integrity in 2015 and 2016. A previous entry addressed two of these, the draft from FDA published in April 2016 and the guidance from EMA posted in August 2016. Here we continue with the guidance from MHRA (effective version HERE and new draft revision HERE), PIC/S, WHO and the recently published Drug Data Management Standard from the China FDA. The English translation herein of the document from China was graciously provided by the China Working Group of Rx-360. Rx-360 is a not for profit consortium led by volunteers from the Pharmaceutical and Biotech industry including both manufacturers and suppliers…READ MORE…

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